Trial results for the LetSync mobile health (mHealth) intervention in HIV/AIDS were posted on ClinicalTrials.gov on 2026-03-23, involving 144 participants.
Background
HIV/AIDS remains a significant global health challenge, requiring consistent adherence to antiretroviral therapy (ART) for effective viral suppression and to prevent disease progression. Poor ART adherence can lead to treatment failure, drug resistance, and increased risk of transmission. Mobile health (mHealth) interventions, utilizing smartphones and other wireless devices, offer a promising avenue to support patients in managing their health, including improving medication adherence and retention in care. The development of user-friendly and effective mHealth tools is crucial for enhancing long-term outcomes for individuals living with HIV.
Trial design
This completed study, designated as Phase NA, was a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention called LetSync. It enrolled 144 participants to investigate conditions related to HIV/AIDS. The trial aimed to assess the acceptability, feasibility, and preliminary impact of LetSync on retention in care and ART adherence. Participants in the intervention arm used LetSync v1.0 for 6 months, while the control arm was a waitlist-control group.
Key results
The trial reported several key measurements comparing the intervention and control arms:
- Proportion of Urine Samples Returned by Participants:
- Intervention Arm: 54 Participants
- Control Arm: 65 Participants
- Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples (ng/mg):
- Intervention Arm: Mean 485.03 (Standard Deviation 603.42)
- Control Arm: Mean 595.55 (Standard Deviation 1172.40)
- Self-reported Measure of Care Engagement (score on a scale):
- Intervention Arm: Mean 31.2 (Standard Deviation 4.38)
- Control Arm: Mean 36.5 (Standard Deviation 6.04)
- Number of Participants Retained:
- Intervention Arm: 61 Participants
- Control Arm: 72 Participants
What this means
The preliminary results from this pilot study indicate that the LetSync mHealth intervention did not demonstrate a superior impact on key adherence and engagement metrics compared to the control arm. The control group showed a higher proportion of urine samples returned, higher mean antiretroviral concentrations in dried blood spot samples, a higher mean self-reported care engagement score, and a greater number of retained participants. As a pilot study, its primary goals included assessing acceptability and feasibility, alongside preliminary impact. These findings suggest that further refinement of the LetSync intervention or additional research may be needed to establish its effectiveness in improving ART adherence and retention in care for individuals with HIV/AIDS.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04951544, titled "LetSync: Pilot Test of Mobile Health (mHealth) Intervention", were posted on 2026-03-23 on clinicaltrials.gov.